Relievant Medsystems, a privately held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced 12-month results from a Level 1, prospective, randomized, multi-center trial that demonstrated the effectiveness and superiority of the Intracept® Procedure for vertebrogenic CLBP compared to standard care treatments.
The INTRACEPT study randomized 140 patients across 20 sites and enrollment was stopped early due to statistical superiority at the pre-specified interim analysis; primary results were published in 2019, showing a significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints at three months post-procedure.
The newly published data report outcomes for the full randomized trial cohort, including six-month between arm comparisons, 12-month treatment arm results, and six-month outcomes post-procedure for patients in the prior standard care arm that elected to crossover and receive BVN ablation upon the trial enrollment being stopped.
The published results demonstrate a 24.5 difference between arms in reduction in mean ODI, with BVN ablation arm (26.1 points, p<0.001) versus standard care arm (1.6 points, p<0.001) at six months post-procedure, validating superiority of the Intracept Procedure compared to standard care.
These outcomes continued through 12 months, with statistically significant and clinically meaningful reductions in mean ODI (25.7 points, p<0.001) and mean VAS (3.8 cm, p<0.001) from baseline through 12 months in the Intracept treatment arm.
Additionally, crossover patients who were re-baselined prior to receiving the Intracept procedure reported nearly identical outcomes, with reductions in mean ODI (25.9 points, p<0.001) and mean VAS (3.8 cm, p<0.001) compared to baseline at six months post-procedure.
Other key results from the study include:
- 64% of patients in the Intracept treatment arm reported ≥50% reduction in pain, while 30% reported they had complete pain resolution at 12 months; similar reductions in pain were reported in crossover patients at six months post-procedure.
- 92% of patients in the Intracept treatment arm who had epidural steroid injections prior to treatment did not have any injections in the 12 months after treatment. Crossover patients reported a 100% reduction in injections six months post-procedure.
- 74% of patients in the Intracept treatment arm reported improvement of their condition, with 75% indicating treatment success at 12 months. Former standard care patients who crossed over to BVN ablation reported similar satisfaction at six months post-procedure (78% improvement, 72% success).
- There were no serious device or procedure-related adverse events.
“Publication of the full INTRACEPT randomized trial results is an important step in proving the clinical effectiveness of BVN ablation and further validating its role in the CLBP care pathway,” said Matthew Smuck, MD, Physical Medicine & Rehabilitation, Stanford University. “Patients in the BVN ablation treatment arm demonstrated clinically and statistically significant improvements vs. those in the standard care arm, with benefits in pain and function lasting 12-months after treatment. Additionally, standard care arm patients who chose to receive BVN ablation reported results consistent with the treatment arm patients at three and six months – demonstrating reproducibility of treatment outcomes.”
“The positive outcomes from the full cohort of the INTRACEPT randomized trial add to the significant portfolio of long-term evidence post-BVN ablation, with patients in the BVN ablation arm showing consistent outcomes with prior long-term studies,” said Tyler Binney, President & CEO, Relievant Medsystems. “Following the publication of positive 5-year data from the SMART trial, these results further demonstrate that outcomes post-Intracept procedure are long-lasting, reproducible, and superior to standard care – with the potential to positively improve the lives of the millions of patients suffering from chronic vertebrogenic low back pain.”
The 12-month publication is currently available in Regional Anesthesia and Pain Medicine via open access and can be found at the following link:
Relievant will host a webinar on Wednesday, June 30 at 7 p.m. CDT to review the outcomes of the study. Register at: www.relievant.com/intracept12
The Intracept procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain in the United States.
About Relievant Medsystems
Relievant Medsystems is a privately held medical device company that is transforming the treatment of Chronic Low Back Pain (CLBP) with the Intracept® Procedure – a novel, clinically proven and commercially available treatment designed to improve the quality of life for the millions of patients suffering from CLBP from degenerative disc disease with Modic changes, a biomarker indicating that their pain is vertebrogenic in origin. Learn more at www.relievant.com.